GENELABS ANNOUNCES RESULTS OF LUPUS DRUG STUDY

Genelabs Technologies announced positive results from a preliminary analysis of an open label clinical trial, which has met its primary objective of maintaining the bone mineral density (BMD) of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids.

The primary endpoint of the study was maintenance of bone-mineral density at the lumbar spine for patients receiving 200 mg of Prestara per day, which has been the standard dose Genelabs has used in clinical evaluation of Prestara. All patients in the study received Prestara, either 100 or 200 mg per day, with approximately two-thirds of the patients receiving 200 mg per day. While the trial was not designed with a placebo control, it was randomized and all of the patients' BMD scans were sent to a centralized reading site. All patients enrolled in the study were taking glucocorticoids, which normally cause a decrease in bone mineral density.

Preliminary results of the study demonstrated that patients who received 200 mg of Prestara per day increased their BMD at the lumbar spine by approximately 0.9 percent during the 12 months they were enrolled. The study also demonstrated that patients who received a lower dose of Prestara, 100 mg per day, did not increase their BMD during the clinical trial, and in fact lost a measurable amount of bone mineral density at the lumbar spine over the 12-month period.